Crohn's DiseaseSUNRISENCT05192863
A Study of Vedolizumab in Adults With Crohn's Disease (CD)
An observational study of Crohn's Disease, run by Takeda at 10 sites in 3 countries.
Trial summary
The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 20 Mar 2023to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with moderately to severely active CD initiating vedolizumab therapy in a routine clinical care, with a BWT of >3 mm, based on IUS assessment.
Who may be able to join
- Has moderately to severely active CD with a BWT of >3 mm, based on IUS performed within the previous 4 weeks from baseline.
- Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).
Who cannot join
- Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
- Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
- Ongoing or planned pregnancy or breastfeeding participants.
- Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
- Characteristics precluding IUS visualization of affected bowel segments or normal BWT of <=3 mm for all segments.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Italy5 sites
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Ospedale San Raffaele
Milan, 20132
ASST Fatebenefratelli Sacco
Milan, 20157
A.O.U. Federico II
Naples, 80131
Ospedale ASST Rhodense
Rho, Milano, 20017
Israel3 sites
Hadassah Medical Center
Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 5262000
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Complete Remission in Patients With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab - A Multicenter, Prospective Observational Cohort Study in Canada, Italy, and Israel
The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography.
Participants will be treated with vedolizumab according to their clinic's standard practice.
Read the detailed description
This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating treatment with vedolizumab according to the current summary of product characteristics (SmPC) in the real world setting.
The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
Participants with CD
This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months.
- Conditions
- Crohn's Disease
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with CD | Participants diagnosed with moderately to severely active CD who are initiating vedolizumab intravenous (IV) induction treatment with the option to switch to vedolizumab subcutaneous (SC) treatment, as maintenance therapy in accordance with the current SmPC will be observed prospectively for 18 months. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy
Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission.Corticosteroid-free defined as no usage of any systemic or locally acting steroid.Corticosteroid-free clinical remission defined as Harvey Bradshaw Index (HBI) less than (<) 5 points and no concomitant corticosteroids.HBI score measures disease activity of CD. Clinical parameters:general well-being (0-4,higher score lower well being),abdominal pain(0-3,higher score more severe pain),number of liquid stools/day, abdominal mass (0-3),higher score presence of swelling in abdomen),complications (score 1/item).Total is sum of individual parameters.Score:minimum 0-no pre-specified maximum score,depends on number of liquid stools, higher scores indicating more severe disease.Biochemical remission defined as C-reactive protein(CRP) and fecal calprotectin (FCal) normalization.Transmural remission defined as bowel wall thickness(BWT) of <3 millimeter (mm) for all bowel segments upon IUS.
Measured: Baseline up to 12 months
Secondary outcomes (18)
Percentage of Participants Who Achieve Complete Remission
Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission. Corticosteroid-free defined as no usage of any systemic or locally acting steroid. Corticosteroid-free clinical remission defined as HBI <5 points and no concomitant corticosteroids. HBI score is used to measure disease activity of CD. Biochemical remission defined as CRP and FCal normalization. Transmural remission defined as BWT of <3 mm for all bowel segments upon Intestinal Ultrasonography (IUS).
Measured: Up to Month 18
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission
Corticosteroid-free defined as no usage of any systemic or locally acting steroid. Corticosteroid-free clinical remission defined as HBI <5 points and no concomitant corticosteroids. HBI score is used to measure disease activity of CD.
Measured: Up to Month 18
Percentage of Participants Who Achieve Biochemical Remission
Biochemical remission defined as CRP and FCal normalization.
Measured: Up to Month 18
Percentage of Participants Who Achieve Transmural Remission
Transmural remission defined as BWT of <3 mm for all bowel segments upon IUS.
Measured: Up to Month 18
Percentage of Participants Who Achieve Clinical Response
Clinical response is defined as a reduction of greater than or equal to (>=) 3 points from the baseline HBI score. HBI score is used to measure the disease activity of CD.
Measured: Up to Month 18
Percentage of Participants Who Achieve Transmural Response
Transmural response is defined as a minimum reduction of 25 percent (%) of BWT from baseline or absolute BWT less than or equal to (<=) 3 mm upon IUS.
Measured: Up to Month 18
Percentage of Participants With Change, and Reason for Change in Vedolizumab Dosing Frequency
Measured: Up to Month 18
Percentage of Participants Who Switched to Vedolizumab SC Formulation
Measured: Up to Month 18
Percentage of Participants Who Discontinued Vedolizumab Treatment and Reason for Discontinuation
Measured: Up to Month 18
Percentage of Participants With Prior Treatments for CD, and Reason for Discontinuation
Measured: Up to Month 18
Percentage of Participants With Concomitant Therapies for CD
Concomitant therapies for CD including introduction and discontinuation of systemic steroids; any changes and reasons for changing including dosing regimen changes, discontinuation, initiation etc.
Measured: Up to Month 18
Percentage of Participants Who Switched to Other CD Therapy After Vedolizumab Discontinuation
Measured: Up to Month 18
Percentage of Participants With Acceptance of IUS Monitoring and Assessment
IUS is a 6 item questionnaire visual analogue scale (VAS). Out of 6 items, 2 items has score range 1 (completely unacceptable) to 10 (completely acceptable): Item 1-Acceptability as monitoring tool in IBD; and Item 2-Acceptability of other monitoring tools in IBD including 6 sub items with score range 1 to 10. Item 3- IUS examination leading to improvement of knowledge of their illness with score range 1 (totally useless) to 10 (very useful). Item 4: Tolerability of IUS with score range 1 (no discomfort) to 10 (much discomfort). Item 5: Choice of monitoring modality with score range 1 (most preferred) to 5 (least preferred). Item 6: IUS examination leading to improvement of knowledge/understanding of illness including 5 sub-items with score range of 1 (completely disagree) to 10 (strongly agree). Responses to these 6 questions will be summed to maximum score of 145. The total score range represents participant's experience of IUS and their acceptability to this assessment.
Measured: Up to Month 18
Percentage of Participants With Improved Quality of Life Based on Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
The SIBDQ is an instrument used to assess quality of life and is a disease-specific HRQoL questionnaire, that consists of 10 questions grouped into four different dimensions: social, bowel, emotional, and systemic, each question is scored on a scale from 1 (a severe problem) to 7 (not a problem at all). The total score will be reported and will range from 10 to 70 with a higher score indicates a better health-related QoL.
Measured: Baseline up to Month 18
Percentage of Participants With CD-related hospitalizations, CD-related emergency room (ER) visits, CD-related surgeries, CD-related flares requiring IV Induction Therapy or IV Corticosteroid Therapy
Health Care Resources Utilization (HCRU) will be calculated as available in the medical record and captured in the eCRF.
Measured: Up to Month 18
Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)
Measured: Up to Month 18
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Measured: Up to Month 18
Number of Participants Reporting one or More Adverse Events of Special Interest (AESIs)
Measured: Up to Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start20 Mar 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192863
- Sponsor's protocol ID
- Vedolizumab-4038
- Acronym
- SUNRISE
- Status last verified
- Nov 2025
- First submitted
- 11 Jan 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Remission in Patients With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab - A Multicenter, Prospective Observational Cohort Study in Canada, Italy, and Israel
- ClinicalTrials.gov ID
- NCT05192863
- Acronym / sponsor ID
- SUNRISE / Vedolizumab-4038
- Conditions
- Crohn's Disease
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography.
Participants will be treated with vedolizumab according to their clinic's standard practice.
Detailed description
This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating treatment with vedolizumab according to the current summary of product characteristics (SmPC) in the real world setting.
The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
Participants with CD
This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CD | – | Other: No InterventionParticipants diagnosed with moderately to severely active CD who are initiating vedolizumab intravenous (IV) induction treatment with the option to switch to vedolizumab subcutaneous (SC) treatment, as maintenance therapy in accordance with the current SmPC will be observed prospectively for 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with moderately to severely active CD initiating vedolizumab therapy in a routine clinical care, with a BWT of >3 mm, based on IUS assessment.
Key inclusion criteria (2 listed)
- Has moderately to severely active CD with a BWT of >3 mm, based on IUS performed within the previous 4 weeks from baseline.
- Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).
Key exclusion criteria (7 listed)
- Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
- Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
- Ongoing or planned pregnancy or breastfeeding participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Participants with CD |
Primary outcome
Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy
Time frame: Baseline up to 12 months
Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission.Corticosteroid-free defined as no usage of any systemic or locally acting steroid.Corticosteroid-free clinical remission defined as Harvey Bradshaw Index (HBI) less than (<) 5 points and no concomitant corticosteroids.HBI score measures disease activity of CD. Clinical parameters:general well-being (0-4,higher score lower well being),abdominal pain(0-3,higher score more severe pain),number of liquid stools/day, abdominal mass (0-3),higher score presence of swelling in abdomen),complications (score 1/item).Total is sum of individual parameters.Score:minimum 0-no pre-specified maximum score,depends on number of liquid stools, higher scores indicating more severe disease.Biochemical remission defined as C-reactive protein(CRP) and fecal calprotectin (FCal) normalization.Transmural remission defined as bowel wall thickness(BWT) of <3 millimeter (mm) for all bowel segments upon IUS.
18 secondary outcomes
Percentage of Participants Who Achieve Complete Remission
Time frame: Up to Month 18
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission
Time frame: Up to Month 18
Percentage of Participants Who Achieve Biochemical Remission
Time frame: Up to Month 18
Percentage of Participants Who Achieve Transmural Remission
Time frame: Up to Month 18
Percentage of Participants Who Achieve Clinical Response
Time frame: Up to Month 18
Percentage of Participants Who Achieve Transmural Response
Time frame: Up to Month 18
Percentage of Participants With Change, and Reason for Change in Vedolizumab Dosing Frequency
Time frame: Up to Month 18
Percentage of Participants Who Switched to Vedolizumab SC Formulation
Time frame: Up to Month 18
Percentage of Participants Who Discontinued Vedolizumab Treatment and Reason for Discontinuation
Time frame: Up to Month 18
Percentage of Participants With Prior Treatments for CD, and Reason for Discontinuation
Time frame: Up to Month 18
Percentage of Participants With Concomitant Therapies for CD
Time frame: Up to Month 18
Percentage of Participants Who Switched to Other CD Therapy After Vedolizumab Discontinuation
Time frame: Up to Month 18
Percentage of Participants With Acceptance of IUS Monitoring and Assessment
Time frame: Up to Month 18
Percentage of Participants With Improved Quality of Life Based on Health-related Quality of Life (HRQoL) as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: Baseline up to Month 18
Percentage of Participants With CD-related hospitalizations, CD-related emergency room (ER) visits, CD-related surgeries, CD-related flares requiring IV Induction Therapy or IV Corticosteroid Therapy
Time frame: Up to Month 18
Number of Participants Reporting one or More Adverse Drug Reactions (ADRs)
Time frame: Up to Month 18
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Time frame: Up to Month 18
Number of Participants Reporting one or More Adverse Events of Special Interest (AESIs)
Time frame: Up to Month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Takeda at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Israel, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieve Complete Remission 12 Months After Initiation of Vedolizumab Therapy (time frame: Baseline up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.